Supervisor, Quality Control Biology

Artiva Biotherapeutics•San Diego, CA

1d•$110,000 - $135,000•Onsite

About The Position

Artiva Biotherapeutics is seeking a skilled and motivated Quality Control Supervisor who will be reporting to the Senior Manager, Quality Control. This individual will supervise the Bio Team and support QC biology testing. The individual will additionally perform routine cGMP release and stability testing of Artiva’s products.

Requirements

Bachelor’s degree (BS/BA) in Biology, Biochemistry, Immunology, or a related life science field required.
Minimum 8 years of cGMP QC experience in a cell therapy/biotech/pharmaceutical setting is required.
At least 1 year of Supervisory or team lead experience is required.
Knowledge and experience in supporting cGMP deviations, OOS, etc.
Basic knowledge of method transfers, qualifications, and validations; current industry practices; and strong experience with guidance interpretation and application
Excellent critical thinking and technical writing skills.
Computer skills required to operate Microsoft Word, Project, Visio, and Excel programs.

Nice To Haves

Experience with NK cell or CAR-modified cell therapy products preferred; familiarity with viability, cytotoxicity, identity, and potency assays for cell therapy products.

Responsibilities

Write and revise SOPs/Test methods that support Artiva’s cell therapy products.
Operate and test ELISA, Flow Cytometers, automated cell counters, and other analytical instruments and equipment, as needed.
Serve as primary QC Biology point of contact for cross-functional teams including Manufacturing, QA, and Regulatory Affairs for release and investigation activities.
Lead training and qualification of Bio team members on equipment use and biological test methods.
Support activities for QC equipment IQ/OQ/PQs.
Lead and perform routine cGMP release and stability testing of Artiva’s products; including biological tests, biochemistry, chemistry-based tests as needed.
Lead evaluation of QC systems and/or implementation of system improvements.
Perform laboratory investigations and write reports for deviations.
Ensure data integrity practices (ALCOA+ principles) are followed by the Bio team; support LIMS/ELN implementation and administration as applicable.
Assist in laboratory investigations for Out of Specification results.
Assist in biological method qualification and validation as needed.
Perform periodic trending of QC testing data; identify adverse trends and initiate CAPAs as appropriate.
Perform all work according to company policies, SOPs, and cGMP practices.
Planning and scheduling for GMP in-process and release testing.
Reviewing biology data and investigating OOS and OOT results.
Write technical QC protocols and reports as needed.
Assist QC and AD team for analytical qualification and validation, as necessary.
Develop an in-depth understanding of NK and CAR-NK products, testing, and safety.
Maintain records and databases in accordance with procedures.